Patients who have lost more than 30% of their blood volume and are in shock

Patients who are at least 18 years old

Patients who have severe injuries

Who will not be in this research study?

Women who are obviously pregnant

Patients who require CPR to maintain their heartbeat

Patients who are known and have proof of objection to blood transfusions

Patients who are wearing a bracelet or necklace stating “NO COMBAT STUDY”

Patients who have a family member at the scene who object to enrollment to the paramedics

]]>https://combatstudy.wordpress.com/2013/01/18/which-patients-can-participate-in-the-combat-study/feed/3ERdhprblog2013What is the Design of the COMBAT Research Study?https://combatstudy.wordpress.com/2013/01/18/what-is-the-design-of-the-combat-research-study/
https://combatstudy.wordpress.com/2013/01/18/what-is-the-design-of-the-combat-research-study/#commentsFri, 18 Jan 2013 20:03:30 +0000http://combatstudy.wordpress.com/?p=56Continue reading →]]>Severely injured patients in “hemorrhagic shock” will be given either saline (salt water) or thawed AB-FP24 plasma as the first treatment fluid. A method of chance, like flipping a coin, is used to decide which treatment the patient will get. The patient is randomized to either the standard (saline (salt water) solution) or experimental (AB-FP24 plasma) group. There is an equal chance of being in either group.

If the patient is assigned to the standard group, he/she will receive saline (salt water) as the first fluid in the ambulance. He/she will then be treated as all trauma patients are treated at the hospital. The doctors who see the patient at the hospital may decide to treat with a red blood cell (RBC) transfusion or AB-FP24 plasma. If blood products are transfused, they are donated blood products. This is the standard of care for all patients who come into the hospital after a severe injury.

If the patient is assigned to the experimental group, he/she will get 2 units AB-FP24 plasma as the first fluid in the ambulance. After the AB-FP24 plasma, the doctors at the hospital may decide that he/she needs a RBC transfusion, saline (salt water) or more AB-FP24 plasma. If more RBC transfusions or AB-FP24 plasma are needed, donated blood products are used.

After the first fluid treatment, both groups are treated in the same way. Blood samples are collected at several times after injury.

]]>https://combatstudy.wordpress.com/2013/01/18/what-is-the-design-of-the-combat-research-study/feed/1Emergency Entrydhprblog2013Who Qualifies for the COMBAT Study?https://combatstudy.wordpress.com/2013/01/18/who-qualifies-for-the-combat-study/
https://combatstudy.wordpress.com/2013/01/18/who-qualifies-for-the-combat-study/#respondFri, 18 Jan 2013 19:59:43 +0000http://combatstudy.wordpress.com/?p=51Continue reading →]]>What is the current standard of care? How are trauma patients usually treated?

Based on the Advanced Trauma Life Support Guidelines from the American College of Surgeons, the current standard of care for trauma patients is to give sterile saline (salt water) through the veins either at the scene or in the ambulance. When the patients arrive at the hospital, they are evaluated and are given blood products including red blood cell and plasma transfusions, if they are bleeding.

How is the control and experimental group different?

Trauma patients in hemorrhagic shock are likely to receive AB-FP24 plasma regardless of the group assigned. The experimental group would receive the AB-FP24 plasma sooner (at the start of the resuscitation period) than the control group (who gets it after the initial evaluation).

Plasma is currently used as the standard treatment of trauma patients, who are actively bleeding. In contrast, red blood cell transfusion is the part of whole blood that has the red blood cells that help carry oxygen. FFP is taken from donors and frozen within 8 hours. Type AB is the universal donor. Since it must be frozen within a short time, there is a limited amount of AB-FFP and limited time to know if the plasma is AB. To have more type AB plasma that can be given to trauma patients, we use plasma that is frozen within 24 hours called AB-FP24 plasma. AB-FP24 plasma is almost the same as AB-FFP. There are smaller amounts of a few specific proteins that help your body clot. This matters for patients who need those specific proteins, but AB-FP24 plasma still works for trauma patients who need clotting proteins after severe injury.AB-FP24 plasma used in this study is collected from pre-screened blood donors at blood banks (i.e. Bonfils Blood Center).

]]>https://combatstudy.wordpress.com/2013/01/18/what-is-plasma/feed/0ERdhprblog2013Regulations of this Studyhttps://combatstudy.wordpress.com/2013/01/18/regulations-of-this-study/
https://combatstudy.wordpress.com/2013/01/18/regulations-of-this-study/#respondFri, 18 Jan 2013 19:57:17 +0000http://combatstudy.wordpress.com/?p=47]]>Regulations established by the Federal government, (21 Code of Federal Regulations §50.24) specify the conditions under which an exception from informed consent in emergency situations is allowed so that research can be carried out even when consent is not possible because of the nature and extent of the patient’s injuries.]]>https://combatstudy.wordpress.com/2013/01/18/regulations-of-this-study/feed/0dhprblog2013Why is the COMBAT Study Being Conducted?https://combatstudy.wordpress.com/2013/01/18/why-is-the-combat-study-being-conducted/
https://combatstudy.wordpress.com/2013/01/18/why-is-the-combat-study-being-conducted/#respondFri, 18 Jan 2013 19:56:08 +0000http://combatstudy.wordpress.com/?p=45Continue reading →]]>Trauma is the leading cause of death among Americans under the age of 45. In spite of major advances in science and medicine over the past 40 years, there have been few, if any major changes, in the early treatment of hemorrhagic shock.

Denver Health is proposing an emergency medicine research study to be conducted over 3 years in the City and County of Denver.

The title of the study is Control Of Massive Bleeding After Trauma (COMBAT) Trial: A prospective, randomized comparison of early fresh frozen plasma versus standard crystalloid intravenous fluid as initial resuscitation fluid.

Why is this research study being conducted?

The purpose of this study is to see if giving thawed plasma earlier to trauma patients will help stop bleeding. Usually we give trauma patients AB-FP24 plasma in the hospital, but we want to see if giving AB-FP24 plasma in the ambulance will help slow or stop their bleeding.

How is this study different from other research studies?

This study is different because it involves patients that cannot give consent and the treatment must be given immediately after injury. In order to do this study without initial consent, we must inform and consult with the public through community outreach before this study will be approved or started. Eligible subjects will be enrolled into the study without their consent unless they have opt out items that can be easily seen.